A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 Versus Chlorambucil in Patients 65 Years or Older With Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (RESONATE™-2)
Study design: This is a randomized, multicenter, open-label, Phase 3 study designed to
compare the safety and efficacy of PCI-32765 versus chlorambucil in treatment-naive patients
65 years or older who have CLL or SLL.
Eligible patients will be randomized in a 1:1 ratio to Treatment Arm A or B:
- Treatment Arm A: Oral chlorambucil 0.5 mg/kg on Days 1 and 15 of each 28-day cycle;
the dose can be increased, if well tolerated, in increments of 0.1 mg/kg on Day 1 of
each cycle to a maximum of 0.8 mg/kg; patients receive a minimum of 3 and a maximum of
12 cycles, in the absence of progressive disease or unacceptable toxicity
- Treatment Arm B: Oral PCI-32765 420 mg/day Randomization will be stratified on Eastern
Cooperative Oncology Group (ECOG) performance status (0,1 versus 2); presence of
advanced Rai stage (yes/no), advanced being defined as Stages 3-4; and geographic
region: US versus non-US.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint of this study is PFS as assessed by IRC review according to IWCLL 2008 criteria with modification for treatment-related lymphocytosis
Assessment of response should include physical examination, radiographic imaging, and evaluation of blood and marrow (if applicable). Patients who withdraw from the study or are considered lost to follow-up without prior documentation of disease progression will be censored on the date of the last adequate disease assessment. Patients who start new anticancer therapy before documentation of disease progression will be censored on the date of the last adequate disease assessment that is on or before the start date of the new anticancer therapy. For patients without an adequate post-baseline disease assessment, PFS will be censored on the date of randomization. Patients who have 2 or more consecutive missing disease assessments immediately before PD or death will be censored for analysis of PFS at the time of last adequate disease assessment. The adequate disease assessment is defined as physical examination and CBC, or CBC and CT scan.
All enrolled patients have completed at least 12 months of treatment and/or follow-up and either (a) 81 progression or death events have been observed or (b) 15 months have elapsed after the last patient is randomized, whichever occurs first.
Yes
Alvina Chu, MD
Study Director
Pharmacyclics
United States: Food and Drug Administration
PCYC-1115-CA
NCT01722487
January 2013
February 2016
Name | Location |
---|---|
University of Michigan | Ann Arbor, Michigan 48109-0624 |
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
City of Hope National Medical Center | Los Angeles, California 91010 |
Stanford Cancer Center | Stanford, California 94305-5824 |
University of Rochester | Rochester, New York 14642 |
Washington University | St. Louis, Missouri 63110 |
UPMC Cancer Pavillion | Pittsburgh, Pennsylvania 15232 |
Peachtree Hematology Oncology Consultants | Atlanta, Georgia 30309 |
UCSD Medical Center Thorton Hospital | La Jolla, California 92307 |
University of Chicago - Oncology Dept | Chicago, Illinois 60637 |
Norton Cancer Institute - Pavilion | Louisville, Kentucky 40202 |
U Mass Memorial University Campus | Worcester, Massachusetts 01655 |
410 Lakeville Road | New Hyde Park, New York 11040 |
Southeastern Medical | Goldsboro, North Carolina 27534 |
South Texas Research Alliance LLC | Laredo, Texas 78041 |
Oncology of San Antonio | San Antonio, Texas 78240 |